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Feasibility of the fecal Pancreas Elastase 1 Quick™ Test for exocrine pancreatic function testing


- candidate number22531
- NTR NumberNTR5344
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-aug-2015
- Secondary IDsW15_194 METC AMC
- Public TitleFeasibility of the fecal Pancreas Elastase 1 Quick™ Test for exocrine pancreatic function testing
- Scientific TitleFeasibility of the fecal Pancreas Elastase 1 Quick™ Test for exocrine pancreatic function testing
- ACRONYMQuick study
- hypothesisTo evaluate the feasibility the fecal Pancreas Elastase 1 Quick™ test (Quick test) for exocrine pancreatic function testing compared to standard fecal Pancreas Elastase 1 test with ELISA (ELISA test).
- Healt Condition(s) or Problem(s) studiedPancreatic insuffiency
- Inclusion criteria‐ Patients with an indication for exocrine pancreatic function testing
‐ Verbal informed consent
- Exclusion criteria‐ <18 years old
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-aug-2015
- planned closingdate
- Target number of participants50
- InterventionsIf a patient at the outpatient clinic has an indication for exocrine pancreatic function testing, the treating physician will request standard fecal elastase test according to standard practice. In addition, patients will be asked for informed consent to participate in the study. If a patient is willing to participate in the study, he will also receive a Quick Test set with an information brochure from the treating physician. The patient will be instructed to perform the Quick test from the same stool sample that will be used for the ELISA test.
- Primary outcomeAccuracy of the Quick test compared with the standard fecal Pancreas Elastase 1 test with ELISA
- Secondary outcome-
- TimepointsAccording to standard practice, the laboratory will perform the ELISA test (results available in 2-4 weeks). The coordinating investigator will collect and process the Quick test set and will report outcomes to the treating physician. The treating physician will report outcomes of the fecal elastase test to the patient when the results of the ELISA test are available.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Lekkerkerker
- CONTACT for SCIENTIFIC QUERIES S. Lekkerkerker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-aug-2015 - 25-aug-2015


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